Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

NCT06106074 | Completed Phase 1 FDA Drug

• 1 other identifier: TDU16831-TDR16862
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.

• In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions
• In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)
• In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)
• In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)
• In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (7)

• Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)

  Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21

• Part 1b: Total (free and bound) SAR442168 concentrations in CSF

  From Day 1 to Day 3

• Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF

  From Day 1 to Day 3

• Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168

  From Day 1 to Day approximately 14

• Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s)

  From Day 1 to Day approximately 14

• Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168

  From Day 1 to Day approximately 14

• Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s)

  From Day 1 to Day approximately 14

Secondary Outcomes (9)

• All Parts: Cmax of SAR442168

  From Day 1 to Day approximately 14

• All Parts: Cmax of SAR442168 metabolite(s)

  From Day 1 to Day approximately 14

• Part 1a, Part 1b and Part 2: tmax of SAR442168

  From Day 1 to Day approximately 14

• Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s)

  From Day 1 to Day approximately 14

• Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168

  From Day 1 to Day approximately 14

Study Arms (5)

Part 1a

EXPERIMENTAL

3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions

Drug: Tolebrutinib; Drug: Placebo

Part 1b

EXPERIMENTAL

2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).

Drug: Tolebrutinib

Part 1c

EXPERIMENTAL

1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).

Drug: Tolebrutinib

Part 1d

EXPERIMENTAL

1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).

Drug: Tolebrutinib

Part 2

EXPERIMENTAL

3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)

Drug: Tolebrutinib; Drug: Placebo

Interventions

Tolebrutinib DRUG

Tablet, oral

Also known as: SAR442168

Part 1a; Part 1b; Part 1c; Part 1d; Part 2

Placebo DRUG

Tablet, oral

Part 1a; Part 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having given written informed consent prior to undertaking any study-related procedure.

You may not qualify if:

• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

New Orleans Clinical Research Site Number : 8400001

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: August 10, 2020
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)